Foot and Ankle Arthrodesis or Osteotomy With Io-Fix Type Fixation : a Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 208
- 试验地点
- 2
- 主要终点
- Radiological and clinical evaluation
研究概览
简要总结
The recovery of foot and ankle arthrodesis and osteotomy is still plagued by the problem of delayed consolidation or even pseudo-arthrosis. To date, the foot and ankle unit of UZ Leuven is using a state of the art system, called the Io-Fix system, to optimize the biomechanical stability.
However, the current literature lacks studies assessing and quantifying the advantages of the Io-Fix system. Objective presentations about the use of, and (early) results are currently missing. Therefore, the investigators want to take their responsibility to objectively investigate whether they can confirm and quantify the expected positive results of using the Io-Fix system. Subsequently, the investigators want to search for eventual unexpected problems with Io-Fix.
详细描述
The recovery of foot and ankle arthrodesis and osteotomy is still plagued by the problem of delayed consolidation or even pseudo-arthrosis. Some known risk factors for delayed consolidation are inherent to the patient and /or cannot be easily corrected by the surgeon: smoking, diabetes mellitus, use of NSAIDS, etc. Many other biological risk factors are well known. The fusion rate is one of these factors. This factor is influenced by the mechanical stability and compression at the level of arthrodesis. The right alignment till the moment of consolidation is an important factor as well.
Currently, two concepts leading to a better fusion rate are under investigation. First, research is done to optimize the local biological factors by using concentrated growth factors. Second, researchers are working towards optimal biomechanical stability and compression by further developing per-operative osteosynthesis material.
Following the optimal biomechanical stability concept, the following innovation was recently released: the Io-Fix system of Extremity Medical L.L.C. (Parsippany , NJ). This state of the art system has clear advantages compared to other systems. Based on the well-expected advantages, the Foot and Ankle unit of UZ Leuven has been using this system since more than one year. The initial subjective results with Io-Fix are strongly positive.
However, the current literature lacks studies assessing and quantifying the advantages of the Io-Fix system. Objective presentations about the use of, and (early) results are currently missing. Therefore, the investigators want to take their responsibility to objectively investigate whether they can confirm and quantify the expected positive results of using the Io-Fix system. Subsequently, the investigators want to search for eventual unexpected problems with Io-Fix.
However, the investigators believe that a larger study groups within a prospective framework with a longer follow-up is mandatory.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being routinely scheduled for a reconstructive surgical procedure for the following indications or involving the following type of procedure
- •Any reconstructive procedure for Pes Planus, Pes Plano-valgus, or Posterior Tibial Tendon Dysfunction
- •Tibio-talar arthrodesis or prosthesis
- •Sub-talar -and/or (partial) Chopart - and/or Triple arthrodesis
- •Pantalar arthrodesis with or without inclusion of the Chopart joint
排除标准
- •Age under 18
研究组 & 干预措施
Foot and ankle arthrodesis or osteotomy
Patients who underwent a foot- or ankle reconstruction surgery using the Io-Fix system
干预措施: Follow-up of Io-Fix type fixation (Other)
结局指标
主要结局
Radiological and clinical evaluation
时间窗: within a period of 1 year
Radiological and clinical evaluation will be combined to determine the fusion rate within a measured time span
次要结局
- Short Form 36 Health Survey Questionnaire (SF-36)(within a period of 1 year)
- American Orthopedic Foot and Ankle Score (AOFAS)(within a period of 1 year)